Heili Kim

Heili Kim is a regulatory attorney who advises food, dietary supplement, cosmetic, medical device, and other companies on federal agency regulatory compliance and advertising related to Food and Drug Administration (FDA) and Federal Trade Commission (FTC) issues. Heili counsels clients on ingredient and product evaluation, claims substantiation, and advertising, and provides risk analysis based on FDA and FTC policies. With her understanding of the domestic and international regulatory and business environments, Heili provides experienced, practical legal advice for companies in the U.S. and those considering or maneuvering in the Asia-Pacific region.

Heili began her career as regulatory counsel with the FDA Center for Food Safety and Applied Nutrition (CFSAN) and established herself in public and private practice over the ensuing years. While in Asia, Heili worked at the Korea-based firm of Kim & Chang, where she assisted multinational drug and food corporations in navigating the Korean market. This included establishing corporate and other entities, gaining market access, achieving product approvals, and overcoming various compliance barriers. She has guided companies through competition and anti-corruption laws—both critical components of doing business in Asia—by ensuring that proper internal business practices are maintained. Following her years in Asia, she developed significant expertise in counseling clients marketing "passively" regulated products such as foods, dietary supplements, cosmetics, and low-risk medical devices. Importantly, Heili’s practice is client focused. By understanding the client’s risk tolerance, objectives, and direction for future expansion, Heili works to allow the company to thrive.

Related Industries

Experience

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Government Experience

Regulatory Counsel, U.S. Food and Drug Administration

Representative Matters

As lead counsel, assisted a large multinational food ingredient company during an international recall of a product that may have been contaminated with a pathogen; the recall spanned four continents and triggered reviews by local and international food safety and health agencies

As lead counsel, advised a large multinational food company on manufacturing issues and assisted in bringing the facility into compliance, recalled products at the retail level, and performed crisis management communications domestically and internationally